Consulting Wallah › Device Explorer › Procedure kits & trays › ENT surgical procedure kit, non-medicated, single-
Device Explorer · FDA GUDID · GMDN 44069

ENT surgical procedure kit, non-medicated, single-use

A collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

US‑registered devices15,061in commercial distribution
Companies19labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Cardinal Health 200, Llc14,80098%
Centurion Medical Products Corporation1291%
Aligned Medical Solutions821%
Deroyal Industries, Inc.130%
Adept Medical Limited50%
Jedmed Instrument Company40%
Medical Action Industries Inc.40%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.40%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc14,80098%
Centurion Medical Products Corporation1291%
Aligned Medical Solutions821%
Deroyal Industries, Inc.130%
Adept Medical Limited50%
Jedmed Instrument Company40%
Medical Action Industries Inc.40%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.40%
Oticon Medical Ab30%
Freudenberg Medical, Llc30%
Medline Industries, Inc.30%
Boston Medical Products, Inc.20%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PontoSingle Use ProfessionalMontgomery® Thyroplasty Instrument SetCARDINAL HEALTHInHealth Technologies; Blom-SingerBR Surgical, LLCDeRoyalCenturionBioseal Inc.Aligned Medical SolutionsDevonStradisMEDLINEADEPT MEDICALHALYARDMEDICAL ACTION INDUSTRIES

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OGREar, nose, and throat surgical tray13,923
OGREar, nose, and throat surgical tray (kit)764
OGREar, Nose, And Throat Surgical Tray170
OGSMyringotomy procedure kit114
OGWTracheostomy kit30
OGHLaryngoscope kit28

GMDN & GCC registration

  • GMDN code 44069 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 4

Use these as the dimensions to specify in a tender line.

How many ent surgical procedure kit, non-medicated, single-use products are registered in the US?

15,061 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "ENT surgical procedure kit, non-medicated, single-use", from 19 companies. The largest labeler is Cardinal Health 200, Llc with 98% of records.

Which FDA product codes apply?

OGR (Ear, nose, and throat surgical tray), OGR (Ear, nose, and throat surgical tray (kit)), OGR (Ear, Nose, And Throat Surgical Tray), OGS (Myringotomy procedure kit)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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